Analytical Method Development and Validation for Estimation of Baricitinib in Bulk and Formulation

Abstract

Baricitinib is an anti-rheumatic agent that is given orally. A simple, accurate, economical, and stable High-Performance Liquid Chromatography (HPLC) method was achieved for the analytical determination of Baricitinib in the tablet dosage form. HPLC systems of Thermo ultimate 3000 was specifically used for the development of the novel method for the drug determination. The chromatographic separation of the selected compound was carried out using Eurosphere C18 column (250mm x 4.6mm i.d.5µ). The defined mobile phase selected was Phosphate buffer (pH 6.5): Acetonitrile associated in the ratio of 70:30 v/v. The flow rate was set at 1.5 ml/minutes with column temperature maintained at 40º C and the injection volume of 20µl. The detection was estimated at 306 nm with the help of UV-VIS detector. The retention time was further observed at 4.9 minutes with the overall run time of approximately 10 minutes. The developed method was found to be linear over the range of 10 to 75 µg/ml with a linear regression coefficient (r²) of 0.9996. The projected technique was found to be within the acceptable limits and with excellent results. The developed HPLC method for best suited with the validation parameters such as robustness, specificity, rapidity, reproducibility, and superior suitable parameter. The HPLC method was validated as per ICH guidelines. Hence the method can be used for the routine analysis of Baricitinib in bulk and tablet.